JP2017525680A - 結晶性抗体製剤 - Google Patents

結晶性抗体製剤 Download PDF

Info

Publication number
JP2017525680A
JP2017525680A JP2017502195A JP2017502195A JP2017525680A JP 2017525680 A JP2017525680 A JP 2017525680A JP 2017502195 A JP2017502195 A JP 2017502195A JP 2017502195 A JP2017502195 A JP 2017502195A JP 2017525680 A JP2017525680 A JP 2017525680A
Authority
JP
Japan
Prior art keywords
seq
antibody
sodium
crystals
crystal
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
JP2017502195A
Other languages
English (en)
Japanese (ja)
Other versions
JP2017525680A5 (enExample
Inventor
ナーゼル カーラフ，
ナーゼル カーラフ，
サラスワティ マンダパティ，
サラスワティ マンダパティ，
リーナ ジェイ． パテル，
リーナ ジェイ． パテル，
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Amgen Inc
Original Assignee
Amgen Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Amgen Inc filed Critical Amgen Inc
Publication of JP2017525680A publication Critical patent/JP2017525680A/ja
Publication of JP2017525680A5 publication Critical patent/JP2017525680A5/ja
Withdrawn legal-status Critical Current

Links

Images

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14—Specific host cells or culture conditions, e.g. components, pH or temperature
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Genetics & Genomics (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
JP2017502195A 2014-07-14 2015-07-13 結晶性抗体製剤 Withdrawn JP2017525680A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201462024393P 2014-07-14 2014-07-14
US62/024,393 2014-07-14
PCT/US2015/040217 WO2016010927A1 (en) 2014-07-14 2015-07-13 Crystalline antibody formulations

Related Child Applications (2)

Application Number Title Priority Date Filing Date
JP2018091269A Division JP2018150337A (ja) 2014-07-14 2018-05-10 結晶性抗体製剤
JP2020115765A Division JP2020172526A (ja) 2014-07-14 2020-07-03 結晶性抗体製剤

Publications (2)

Publication Number Publication Date
JP2017525680A true JP2017525680A (ja) 2017-09-07
JP2017525680A5 JP2017525680A5 (enExample) 2018-06-21

Family

ID=53836192

Family Applications (3)

Application Number Title Priority Date Filing Date
JP2017502195A Withdrawn JP2017525680A (ja) 2014-07-14 2015-07-13 結晶性抗体製剤
JP2018091269A Pending JP2018150337A (ja) 2014-07-14 2018-05-10 結晶性抗体製剤
JP2020115765A Pending JP2020172526A (ja) 2014-07-14 2020-07-03 結晶性抗体製剤

Family Applications After (2)

Application Number Title Priority Date Filing Date
JP2018091269A Pending JP2018150337A (ja) 2014-07-14 2018-05-10 結晶性抗体製剤
JP2020115765A Pending JP2020172526A (ja) 2014-07-14 2020-07-03 結晶性抗体製剤

Country Status (7)

Country Link
US (2) US20170198059A1 (enExample)
EP (1) EP3169710A1 (enExample)
JP (3) JP2017525680A (enExample)
AU (2) AU2015289874A1 (enExample)
CA (1) CA2954767A1 (enExample)
MX (1) MX2017000527A (enExample)
WO (1) WO2016010927A1 (enExample)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017525679A (ja) * 2014-07-14 2017-09-07 アムジェン インコーポレイテッド 結晶性抗体製剤
JP2020535223A (ja) * 2017-09-26 2020-12-03 バイオコン バイオロジックス インディア リミテッドＢｉｏｃｏｎ Ｂｉｏｌｏｇｉｃｓ Ｉｎｄｉａ Ｌｉｍｉｔｅｄ ペプチド結晶の分離、洗浄および乾燥のための統合され、自動化された濾過

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2954767A1 (en) * 2014-07-14 2016-01-21 Amgen Inc. Crystalline antibody formulations
US20170056504A1 (en) * 2015-09-02 2017-03-02 Kenneth I. Kohn Method of extending half-life of crystaline antibodies
JP7229933B2 (ja) 2017-03-14 2023-02-28 アムジェン インコーポレイテッド 結晶性生体分子を対象にする方法
US12257343B2 (en) 2017-04-28 2025-03-25 Amgen Inc. Excipients to reduce the viscosity of antibody formulations and formulation compositions
AU2018258676B2 (en) * 2017-04-28 2024-09-19 Amgen Inc. N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides
GB2584687B (en) * 2019-06-11 2023-08-23 Univ Newcastle Crystallisation of chemical molecules

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005502589A (ja) * 2000-12-28 2005-01-27 アルタス バイオロジックス インコーポレイテッド 抗体全体またはそのフラグメントの結晶、ならびにこの結晶を作製および使用するための方法
JP2010536384A (ja) * 2007-08-23 2010-12-02 アムジエン・インコーポレーテツド プロタンパク質コンベルターゼスブチリシンケクシン９型（ｐｃｓｋ９）に対する抗原結合タンパク質
WO2012154999A1 (en) * 2011-05-10 2012-11-15 Amgen Inc. Methods of treating or preventing cholesterol related disorders
JP2017525679A (ja) * 2014-07-14 2017-09-07 アムジェン インコーポレイテッド 結晶性抗体製剤

Family Cites Families (52)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0766564A4 (en) 1994-06-24 1998-09-23 Immunex Corp SLOW RELEASE POLYPEPTIDES COMPOSITIONS AND METHODS FOR TREATING INFLAMMATORY BOWEL CONDITIONS
IL112834A (en) 1995-03-01 2000-12-06 Yeda Res & Dev Pharmaceutical compositions for controlled release of soluble receptors
US6020004A (en) 1997-04-17 2000-02-01 Amgen Inc. Biodegradable microparticles for the sustained delivery of therapeutic drugs
US6541606B2 (en) 1997-12-31 2003-04-01 Altus Biologics Inc. Stabilized protein crystals formulations containing them and methods of making them
US6432449B1 (en) 1998-05-18 2002-08-13 Amgen Inc. Biodegradable sustained-release alginate gels
US6541033B1 (en) 1998-06-30 2003-04-01 Amgen Inc. Thermosensitive biodegradable hydrogels for sustained delivery of leptin
US6451346B1 (en) 1998-12-23 2002-09-17 Amgen Inc Biodegradable pH/thermosensitive hydrogels for sustained delivery of biologically active agents
US6245740B1 (en) 1998-12-23 2001-06-12 Amgen Inc. Polyol:oil suspensions for the sustained release of proteins
US8821086B2 (en) * 2006-12-22 2014-09-02 Tennine Corporation Method and apparatus for controlled-fracture machining
WO2008109871A2 (en) * 2007-03-08 2008-09-12 Irm Llc Crystal structure of proprotein convertase 9 (pcsk9) and uses thereof
TW200906439A (en) * 2007-04-13 2009-02-16 Novartis Ag Molecules and methods for modulating proprotein convertase subtilisin/kexin type 9 (PCSK9)
US20130072665A1 (en) * 2007-08-23 2013-03-21 Simon Mark Jackson Antigen binding proteins to proprotein convertase subtilisin kexin type 9 (pcsk9)
WO2009131740A2 (en) * 2008-04-23 2009-10-29 Amgen Inc. Neutralizing proprotein convertase subtilisin kexin type 9 (pcsk9) variants and uses thereof
KR100985090B1 (ko) * 2008-05-23 2010-10-04 한국과학기술연구원 크라이센 노출 여부 확인용 바이오마커 및 이를 이용한확인 방법
WO2011028938A1 (en) * 2009-09-02 2011-03-10 Alnylam Pharmaceuticals, Inc. Methods for lowering serum cholestrol in a subject using inhibition of pcsk9
JO3244B1 (ar) 2009-10-26 2018-03-08 Amgen Inc بروتينات ربط مستضادات il – 23 البشرية
IN2012DN03824A (enExample) * 2009-10-30 2015-08-28 Merck Sharp & Dohme
JO3756B1 (ar) * 2010-11-23 2021-01-31 Regeneron Pharma اجسام مضادة بشرية لمستقبلات الجلوكاجون
HRP20180959T1 (hr) * 2011-01-28 2018-07-27 Sanofi Biotechnology Ljudska protutijela za pcsk9 za uporabu u postupcima liječenja određenih skupina subjekata
US20140004122A1 (en) * 2011-05-10 2014-01-02 Amgen Inc. Methods for treating or preventing cholesterol related disorders
ITPN20110039A1 (it) * 2011-05-24 2012-11-25 Keyline S P A Blocchetto di presa perfezionato per macchina duplicatrice di chiavi
AR087305A1 (es) * 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
EA039663B1 (ru) * 2012-05-03 2022-02-24 Амген Инк. Применение антитела против pcsk9 для снижения сывороточного холестерина лпнп и лечения связанных с холестерином расстройств
US9255154B2 (en) * 2012-05-08 2016-02-09 Alderbio Holdings, Llc Anti-PCSK9 antibodies and use thereof
WO2013170367A1 (en) * 2012-05-17 2013-11-21 The University Of British Columbia Methods and uses for proprotein convert ase subtilisin kexin 9 (pcsk9) inhibitors
RU2015101113A (ru) * 2012-06-15 2016-08-10 Дженентек, Инк. Антитела против pcsk9, составы, дозы и способы применения
WO2014107657A2 (en) * 2013-01-04 2014-07-10 Kohn Kenneth I Cholesterol-lowering compounds in combination with lipid metabolism-altering compounds of non-absorbable sugars, compounds that convert nh3 to nh4+, or hydrogen-generating compounds for the treatment of high cholesterol and inflammation
ES2834113T3 (es) * 2013-03-15 2021-06-16 H Lundbeck As Purificación de anticuerpos y monitorización de la pureza
JP2016514668A (ja) * 2013-03-15 2016-05-23 アムジエン・インコーポレーテツド プロタンパク質コンベルターゼスブチリシンケクシン９型に結合するヒト抗原結合タンパク質
CN111920954A (zh) * 2013-06-07 2020-11-13 再生元制药公司 通过施用pcsk9抑制剂抑制动脉粥样硬化的方法
US20150004174A1 (en) * 2013-06-28 2015-01-01 Amgen Inc. Methods for treating homozygous familial hypercholesterolemia
AU2013396206B2 (en) * 2013-06-28 2019-11-14 Amgen Inc. Methods for treating homozygous familial hypercholesterolemia
CN115192704A (zh) * 2013-10-11 2022-10-18 赛诺菲生物技术公司 Pcsk9抑制剂用于治疗高血脂症的用途
CN106062003A (zh) * 2013-11-12 2016-10-26 赛诺菲生物技术公司 用于与pcsk9抑制剂一起使用的给药方案
US9023359B1 (en) * 2014-07-15 2015-05-05 Kymab Limited Targeting rare human PCSK9 variants for cholesterol treatment
US9034332B1 (en) * 2014-07-15 2015-05-19 Kymab Limited Precision medicine by targeting rare human PCSK9 variants for cholesterol treatment
US8883157B1 (en) * 2013-12-17 2014-11-11 Kymab Limited Targeting rare human PCSK9 variants for cholesterol treatment
CA2939507A1 (en) * 2014-02-14 2015-08-20 Regeneron Pharmaceuticals, Inc. Methods for treating patients with hypercholesterolemia that is not adequately controlled by moderate-dose statin therapy
WO2015127273A1 (en) * 2014-02-21 2015-08-27 Medimmune, Llc Anti-pcsk9~glp-1 fusions and methods for use
WO2015140079A1 (en) * 2014-03-17 2015-09-24 Sanofi Methods for treating subjects with primary hypercholesterolemia that is not adequately controlled
US20150284473A1 (en) * 2014-03-17 2015-10-08 Laurence Bessac Methods for reducing cardiovascular risk
CA2954767A1 (en) * 2014-07-14 2016-01-21 Amgen Inc. Crystalline antibody formulations
KR20170029613A (ko) * 2014-07-16 2017-03-15 사노피 바이오테크놀로지 이형접합성 가족성 고콜레스테롤혈증(heFH) 환자의 치료방법
US10472424B2 (en) * 2014-09-23 2019-11-12 Pfizer Inc. Treatment with anti-PCSK9 antibodies
EP3439715B1 (en) * 2016-04-08 2021-03-10 Amgen Inc. Drug delivery device
WO2017186928A1 (en) * 2016-04-29 2017-11-02 Curevac Ag Rna encoding an antibody
KR102551269B1 (ko) * 2016-09-29 2023-07-05 암젠 인크 저-점도 항원 결합 단백질 및 이의 제조 방법
MA46466A (fr) * 2016-10-06 2019-08-14 Amgen Inc Formulations pharmaceutiques de protéines à viscosité réduite
JOP20190112A1 (ar) * 2016-11-14 2019-05-14 Amgen Inc علاجات مدمجة لتصلب الشرايين، شاملة مرض قلبي وعائي تصلبي
US20190031774A1 (en) * 2017-06-09 2019-01-31 Sanofi Biotechnology Methods for treating hyperlipidemia in diabetic patients by administering a pcsk9 inhibitor
AU2018350992A1 (en) * 2017-10-18 2020-05-21 Regenxbio Inc. Fully-human post-translationally modified antibody therapeutics
CA3106115A1 (en) * 2018-07-08 2020-01-16 Specifica Inc. Antibody libraries with maximized antibody developability characteristics

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005502589A (ja) * 2000-12-28 2005-01-27 アルタス バイオロジックス インコーポレイテッド 抗体全体またはそのフラグメントの結晶、ならびにこの結晶を作製および使用するための方法
JP2010536384A (ja) * 2007-08-23 2010-12-02 アムジエン・インコーポレーテツド プロタンパク質コンベルターゼスブチリシンケクシン９型（ｐｃｓｋ９）に対する抗原結合タンパク質
WO2012154999A1 (en) * 2011-05-10 2012-11-15 Amgen Inc. Methods of treating or preventing cholesterol related disorders
JP2017525679A (ja) * 2014-07-14 2017-09-07 アムジェン インコーポレイテッド 結晶性抗体製剤

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
BIOTECHNOL. PROG., vol. 27, no. 4, JPN6019012680, 2011, pages 1054 - 1067, ISSN: 0004224493 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017525679A (ja) * 2014-07-14 2017-09-07 アムジェン インコーポレイテッド 結晶性抗体製剤
JP2020535223A (ja) * 2017-09-26 2020-12-03 バイオコン バイオロジックス インディア リミテッドＢｉｏｃｏｎ Ｂｉｏｌｏｇｉｃｓ Ｉｎｄｉａ Ｌｉｍｉｔｅｄ ペプチド結晶の分離、洗浄および乾燥のための統合され、自動化された濾過
JP7213254B2 (ja) 2017-09-26 2023-01-26 バイオコン バイオロジックス インディア リミテッド ペプチド結晶の分離、洗浄および乾燥のための統合され、自動化された濾過

Also Published As

Publication number Publication date
AU2021201422A1 (en) 2021-03-25
AU2015289874A1 (en) 2017-02-02
WO2016010927A1 (en) 2016-01-21
US20190127485A1 (en) 2019-05-02
US20170198059A1 (en) 2017-07-13
CA2954767A1 (en) 2016-01-21
JP2018150337A (ja) 2018-09-27
US11267902B2 (en) 2022-03-08
JP2020172526A (ja) 2020-10-22
EP3169710A1 (en) 2017-05-24
MX2017000527A (es) 2017-08-10

Similar Documents

Publication Publication Date Title
US11267902B2 (en) Crystalline antibody formulations
JP7264853B2 (ja) 結晶性抗体製剤
JP6412964B2 (ja) 抗スクレロスチン抗体結晶およびその製剤
HK1192570A (en) Anti-sclerostin antibody crystals and formulations thereof
HK1192570B (en) Anti-sclerostin antibody crystals and formulations thereof

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20180510

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20180510

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20190313

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20190411

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20190702

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20190910

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20191011

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20200303

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20200703

A911 Transfer to examiner for re-examination before appeal (zenchi)

Free format text: JAPANESE INTERMEDIATE CODE: A911

Effective date: 20200720

A761 Written withdrawal of application

Free format text: JAPANESE INTERMEDIATE CODE: A761

Effective date: 20200727